House Passes Device User Fee Bill

The U.S. House of Representatives has passed the Medical Device User Fee Stabilization Act of 2005, leading the way for the U.S. Senate to vote on the bill soon. If approved and signed by President Bush, the bill would bring relief to medical device manufacturers who have seen user fees skyrocket since they were originally enacted in 2003.

According to the Medical Device Manufacturers Association (MDMA), the proposed legislation includes numerous revisions to the original bill, which the medical device industry has criticized for huge fee rate increases. Under the bill, rate increases would be capped at 8.5% annually (previous increases have been as high as 34%). Additionally, the bill would keep the user fee program intact while offering other forms of relief to manufacturers, including:

 —Raising the small business revenues threshold from $30 million to $100 million for PMAs, PMA supplements and 510(k)s, although the first PMA waiver remains at $30 million;

 —Eliminating the workload and compensating adjustments for FDA. The MDMA said this single factor is repsonsible for 55-60% of the rate increases to date;

—Forgiving industry and Congress for any revenue shortfalls;

—Calling for full congressional funding in FY 2006 and 2007;

—Modifying labeling requirements to reprocessors only.

The bill, similar to one approved by a Senate committee last week, will go to the full Senate for approval. If passed, President Bush is likely to sign it into law shortly.